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Scottish Statutory Instruments

2005 No.92

FOOD

The Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005

Made

1st March 2005

Laid before the Scottish Parliament

1st March 2005

Coming into force

24th March 2005

The Scottish Ministers in exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990(1) and of all other powers enabling them in that behalf, having had regard, in accordance with section 48(4A)(2) of that Act, to relevant advice given by the Food Standards Agency, hereby make the following Regulations:

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 and come into force on 24th March 2005.

(2) These Regulations extend to Scotland only.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998

2. The Plastic Materials and Articles in Contact with Food Regulations 1998(3) (“the principal Regulations”) are amended in accordance with regulations 3 to 16 of these Regulations.

3. In regulation 2 (interpretation) paragraph (1)–

(a)for the definition of “additive” substitute–

““additive” means a substance as defined in paragraph 1 of the general introduction to Annex III to the Directive as read with paragraph 3 of article 4 of the Directive;”;

(b)after the definition of “Council Directive 82/711” insert–

““Council Directive 88/388” means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(4) as corrected by a corrigendum dated 14th December 1988(5) and as amended by Commission Directive 91/71(6);

“Council Directive 89/107” means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption(7) as amended by European Parliament and Council Directive 94/34(8);”;

(c)at the end of the definition of “the Directive” insert “and Commission Directive 2004/19/EC”(9);

(d)omit the definition of “EEA Agreement”;

(e)for the definition of “EEA State” substitute ““EEA State” means a Member State (other than the United Kingdom), Norway, Iceland or Liechtenstein;”;

5. In regulation 5 (restriction on the use of additives in the manufacture of plastic materials and articles)–

(a)at the end of paragraph (1) insert–

“(e)any food additive authorised by Council Directive 89/107 or any flavouring authorised by Council Directive 88/388 that migrates into food–

(i)in a quantity that has a technicological function in the final food product; or

(ii)where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for that additive or flavouring in Council Directive 89/107 or Council Directive 88/388 as appropriate, or in Schedule 2 to these Regulations, whichever is the lower;

“Applications for inclusion of an additive in the Community list of authorised additives

5B.—(1)This regulation applies to any person who wishes to make an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive.

(2)An application mentioned in paragraph (1) including supporting data must be made to EFSA before 1st January 2007.

(3)If, during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if otherwise lawful, continue to be so used until EFSA has issued an opinion, provided such information is submitted within the time limits specified by EFSA.

(4)For the purposes of this regulation an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.”.

7. For regulation 8 (labelling) substitute–

“8.At marketing stages other than the retail stage a person who is in possession of any plastic material or article intended to come into contact with food shall ensure that the plastic material or article is accompanied by a written declaration which–

(a)attests that it complies with the legislation applicable to it; and

(b)provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning–

(i)the levels of migration specific to those substances;

(ii)where appropriate, purity criteria in accordance with the purity Directives

sufficient to enable the user of those materials and articles to comply with the legislation applicable to food.”.

8. In regulation 10 (offences)–

(a)in paragraph (1) for “8(1)” substitute “8”;

(b)after paragraph (24) insert–

“(25)In any proceedings for an offence under these Regulations it shall be a defence to prove that–

(a)the act constituting the offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 1st March 2006; and

(b)the act constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 had not been in force at the time that act occurred.”.

9. In Schedule 1, Part I–

(a)in Section A (monomers authorised without time limit)–

(i)insert in the appropriate numerical order the entries set out in Schedule 1 to these Regulations;

(ii)for items 15A, 39, 70, 120B, 147, 147A, 147B and 188 substitute the entries set out in Schedule 2 to these Regulations; and

“(26)QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(27)SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(28)SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(31)Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D (unstable).

(32)QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.”

11. In Schedule 2, Part I (incomplete list of additives used in the manufacture of plastic materials and articles)–

(a)insert in appropriate numerical order the entries set out in Schedule 3 to these Regulations;

(b)for items 60A and 198A substitute the entries set out in Schedule 4 to these Regulations;

“(25)QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(26)QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(27)SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(28)SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(29)SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120.

(30)Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.

(31)Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D (unstable).

(32)QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.

(33)SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360.”;

(b)in paragraph 5 for “1st January 2004” substitute “1st July 2006”.

14. In Schedule 2A (products obtained by bacterial fermentation)–

(a)for the entry in Column 2 (CASNo.) substitute “080181-31-3”;

(b)for the entry in Column 4 (restrictions and specifications) substitute–

“In compliance with specifications included in Schedule 2B”.

15. For Schedule 2B (specifications) substitute the contents of Schedule 6 to these Regulations.

16. For paragraph 4(b) of Part I (basic rules) of Schedule 4 (overall and specific migration testing using food simulants) substitute–

“(b)omit the migration, the substitute or the alternative tests where–

(i)there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or

(ii)the conditions for non–compulsory testing set out in article 8.2 or 8.3 of the Directive are met.”.

RHONA BRANKIN

Authorised to sign by the Scottish Ministers

St Andrew’s House, Edinburgh

1st March 2005

Regulation 9(a)(ii)

SCHEDULE 1(ENTRIES TO BE INSERTED IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS)

“1

2

3

4

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

6A

10599/90A

061788–89–4

Acids, fatty, unsaturated (C18), dimers, distilled

QMA(T) = 0.05 mg/6 dm2 (26)

6B

10599/91

061788–89–4

Acids, fatty, unsaturated (C18), dimers, non distilled

QMA(T) = 0.05 mg/6 dm2 (26)

6C

10599/92A

068783–41–5

Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

QMA(T) = 0.05 mg/6 dm2 (26)

6D

10599/93

068783–41–5

Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled

QMA(T) = 0.05 mg/6 dm2 (26)

37A

13323

000102–40–9

1,3-Bis(2-hydroxyethoxy) benzene

SML = 0.05 mg/kg

68MA

14800

003724–65–0

Crotonic acid

QMA(T) = 0.05 mg/6 dm2 (32)

87A

16210

006864–37–5

3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane

SML = 0.05 mg/kg (31). To be used only in polyamides.

89A

16540

000102–09–0

Diphenyl carbonate

SML = 0.05 mg/kg

101A

17110

016219–75–3

5-Ethylidenebicyclo[2,2,1]hept-2-ene

QMA = 0.05 mg/6 dm2.

The ratio surface / quantity of food shall be lower than 2 dm2/kg

118MA

18700

000629–11–8

1,6-Hexanediol

SML = 0.05 mg/kg

120ZA

18896

001679–51–2

4&-(Hydroxymethyl)-1-cyclohexene

SML = 0.05 mg/kg

135BM

20440

000097–90–5

Methacrylic acid, diester with ethyleneglycol

SML = 0.05 mg/kg

142A

21400

054276–35–6

Methacrylic acid, sulphopropyl ester

QMA = 0.05 mg/6 dm2

156XA

22775

000144–62–7

Oxalic acid

SML(T) = 6 mg/kg(28)

161A

23070

000102–39–6

(1,3-Phenylenedioxy)diacetic acid

QMA = 0.05 mg/6 dm2”

Regulation 9(a)(ii)

SCHEDULE 2(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS)

“1

2

3

4

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

15A

11530

00999–61–1

Acrylic acid, 2-hydroxypropyl ester

QMA = 0.05 mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 2B

SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC

182A

69920

000144–62–7

Oxalic acid

SML(T) = 6 mg/kg (28)

195D

76866

—

Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12–C18 or n-octanol and / or n-decanol

SML = 30 mg/kg

240ZA

85601

—

Silicates, natural (with the exception of asbestos)

280B

95000

028931–67–1

Trimethylolpropane trimethacrylatemethyl methacrylate copolymer”

Regulation 11(b)

SCHEDULE 4(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS)

“1

2

3

4

Item

PM/REF No.

CAS No.

Name

Restrictions and specifications

60A

45450

068610–51–5

p-Cresol-dicyclopentadiene-isobutylene, copolymer

SML = 5 mg/kg

198A

77895

068439–49–6

Polyethyleneglycol (EO = 2–6) monoalkyl (C16–C18) ether

SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 2B”

Regulation 12(a)

SCHEDULE 5(ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

SCHEDULE 6(SUBSTITUTE FOR SCHEDULE 2B TO THE PRINCIPAL REGULATIONS)

“SCHEDULE 2BSPECIFICATIONS

It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918–23–2)

2

16690

Divinylbenzene

It may contain up to 45% (m/m) of Ethylvinylbenzene

3

18888

3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

Definition

The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild–type organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster / working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications.

Chemical name

Poly(3-D-hydroxybutanoate-co–3-D-hydroxypentanoate)

CAS number

080181–31–3

Structural formula

where n / (m + n) greater than 0 and less or equal to 0.25

Average molecular weight

Not less than 150 000 Daltons (measured by gel permeation chromatography)

Assay

Not less than 98% poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids

Description

White to off-white powder after isolation

Characteristics

Identification tests:

Solubility

Soluble in chlorinated hydrocarbons such as a chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water

Restriction

QMA for crotonic acid is 0.05 mg/6 dm2

Purity

Prior to granulation the raw material copolymer powder must contain:

— nitrogen

Not more than 2 500 mg/kg of plastic

— zinc

Not more than 100 mg/kg of plastic

— copper

Not more than 5 mg/kg of plastic

— lead

Not more than 2 mg/kg of plastic

— arsenic

Not more than 1 mg/kg of plastic

— chromium

Not more than 1 mg/kg of plastic

4

23547

Polydimethylsiloxane (Mw > 6800)

Minimum viscosity 100 × 10−6 m2/s (= 100 centistokes) at 25°C

5

25385

Triallylamine

40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use.

6

38320

4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl) stilbene

Not more than 0.05% w/w (quantity of substance used / quantity of the formulation)

(a)substituting the definition of “additive” used in the Directive, for consistency (regulation 3(a));

(b)removing references to lists of substances whose authorisations are now spent (regulation 4(a));

(c)extending to articles the provisions of regulation 4(5) of the 1998 Regulations that formerly only applied to materials (regulation 4(b));

(d)adding a restriction on the use of additives in the manufacture of plastic materials and articles which relates to substances also used as food additives or flavourings (regulation 5(a));

(e)extending to articles the provisions of regulation 5(4) of the 1998 Regulations that formerly only applied to materials (regulation 5(b));

(f)making provision for the procedure to be followed and the time limits to be observed by any person wishing to have an additive included in the Community list of authorised additives (regulation 6);

(g)imposing additional labelling requirements for plastic materials and articles at the pre-retail stage so as to make additional information available to users (regulation 7);

(h)making a consequential amendment to regulation 10 (offences) brought about by the amendment to the labelling requirements (regulation 8(a));

(i)providing a defence to breach the 1998 Regulations as last amended by these Regulations in respect of plastic materials or articles manufactured or imported into the European Community before 1st March 2006 (regulation 8(b)).

They also amend the Schedules to the 1998 Regulations by–

(a)inserting new entries, and amending or deleting some existing ones, in the list of monomers authorised without time limit in Section A of Part I of Schedule 1 (regulation 9(a) and Schedules 1 & 2);

(b)removing the list of entries for monomers authorised with a time limit that has now expired (regulation 9(b));

(c)adding further supplementary specifications in Part II of Schedule 1 (regulation 10);

(d)inserting new entries and amending or deleting some existing entries in the list of additives used in the manufacture of plastic materials and articles in Part I of Schedule 2 (regulation 11 and Schedules 3 & 4);

(e)inserting new entries and deleting some existing entries in the list of additives used in the manufacture of plastic materials and articles set out I Part II of Schedule 2 (regulation 12 and Schedule 5);

(f)adding further supplementary specifications to Part III of Schedule 2, and extending the time limit applicable to substances listed in Part II of that Schedule (regulation 13);

(g)amending the restrictions and specifications in the entry in Schedule 2A relating to products obtained by bacterial fermentation (regulation 14);

(h)inserting new entries and amending or deleting some existing ones in the specifications set out in Schedule 2B (regulation 15 and Schedule 6);adding a provision to the basic rules for overall and specific migration testing using food simulants set out in Part I of Schedule 4, to allow for migration testing to be omitted in the specific circumstances provided for in the Directive (regulation 16).

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.

(1)

1990 c. 16; section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990; sections 16(2) and 48(1) were amended by paragraph 8 of Schedule 5 to the Food Standards Act 1999 (“the 1999 Act”); section 17(1) was amended by paragraphs 8 and 12 of Schedule 5 to the 1999 Act; section 26(3) was amended by Schedule 6 to the 1999 Act; section 48(4) is disapplied in respect of these Regulations by virtue of section 48(4C), inserted by S.I. 2004/2990; amendments made by Schedule 5 to the 1999 Act which extend to Scotland shall be taken as pre-commencement enactments for the purposes of the Scotland Act 1998 (c. 46) (“the 1998 Act”) by virtue of section 40(2) of the 1999 Act. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act.

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